JP7547215B2 - テトラヒドロビオプテリン血漿曝露を増加させるための組成物及び方法 - Google Patents

テトラヒドロビオプテリン血漿曝露を増加させるための組成物及び方法 Download PDF

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JP7547215B2
JP7547215B2 JP2020566737A JP2020566737A JP7547215B2 JP 7547215 B2 JP7547215 B2 JP 7547215B2 JP 2020566737 A JP2020566737 A JP 2020566737A JP 2020566737 A JP2020566737 A JP 2020566737A JP 7547215 B2 JP7547215 B2 JP 7547215B2
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sepiapterin
food
administration
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acid
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JP2021525746A (ja
JP2021525746A5 (cg-RX-API-DMAC10.html
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ニール スミス,
ジョナサン レイス,
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ピーティーシー セラピューティクス エムピー,インコーポレイテッド
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2020566737A 2018-05-30 2019-05-30 テトラヒドロビオプテリン血漿曝露を増加させるための組成物及び方法 Active JP7547215B2 (ja)

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JP2024146283A JP7855033B2 (ja) 2018-05-30 2024-08-28 テトラヒドロビオプテリン血漿曝露を増加させるための組成物及び方法

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US201862677926P 2018-05-30 2018-05-30
US62/677,926 2018-05-30
US201862771397P 2018-11-26 2018-11-26
US62/771,397 2018-11-26
US201962822365P 2019-03-22 2019-03-22
US62/822,365 2019-03-22
GC201937662 2019-05-28
GC2019-37662 2019-05-28
PCT/US2019/034515 WO2019232126A1 (en) 2018-05-30 2019-05-30 Compositions and methods for increasing tetrahydrobiopterin plasma exposure

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JP2024146283A Active JP7855033B2 (ja) 2018-05-30 2024-08-28 テトラヒドロビオプテリン血漿曝露を増加させるための組成物及び方法

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Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110312721A (zh) 2016-11-29 2019-10-08 显莎制药公司 墨蝶呤的多晶型物
WO2018102315A1 (en) 2016-11-29 2018-06-07 Censa Pharmaceuticals Inc. Polymoprhs of sepiapterin and salts thereof
MX2020002271A (es) 2017-09-01 2020-10-05 Ptc Therapeutics Mp Inc Composiciones farmaceuticas que comprenden sepiapterina y sus usos de las mismas.
CA3102105A1 (en) 2018-05-30 2019-12-05 Ptc Therapeutics Mp, Inc. Compositions and methods for increasing tetrahydrobiopterin plasma exposure
JP7778477B2 (ja) 2018-05-30 2025-12-02 ピーティーシー セラピューティクス エムピー,インコーポレイテッド セピアプテリンの薬学的に許容される塩
JP7502197B2 (ja) * 2018-05-30 2024-06-18 ピーティーシー セラピューティクス エムピー,インコーポレイテッド セピアプテリン血漿曝露を増加させるための方法
LT4009978T (lt) 2019-08-05 2024-11-25 Ptc Therapeutics Mp, Inc. Sepiapterino ir jo metabolitų panaudojimas spinduliuotės poveikio gydymui
CA3165636A1 (en) * 2020-01-24 2021-07-29 Neil Smith Methods for treating parkinson's disease with sepiapterin
US12691119B2 (en) 2021-02-09 2026-07-28 Ptc Therapeutics Mp, Inc. Methods for treating covid-19 with sepiapterin
US12298026B1 (en) 2021-04-12 2025-05-13 W. L. Gore & Associates, Inc. Latent energy transfer laminate for plate pack core

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010523708A (ja) 2007-04-11 2010-07-15 バイオマリン ファーマシューティカル インコーポレイテッド テトラヒドロビオプテリンを投与する方法、関連する組成物および測定方法
WO2011132435A1 (ja) 2010-04-22 2011-10-27 学校法人日本大学 脳機能障害予防・改善用の薬剤及び飲食物
US20130108694A1 (en) 2011-11-02 2013-05-02 Biomarin Pharmaceutical Inc. Dry blend formulation of tetrahydrobiopterin

Family Cites Families (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5925323A (ja) 1982-03-03 1984-02-09 鐘淵化学工業株式会社 プテリン誘導体からなる脳内神経伝達物質の関わる疾病の治療剤
US5910304A (en) 1982-12-13 1999-06-08 Texas A&M University System Low-dose oral administration of interferons
CA1320905C (en) 1986-11-06 1993-08-03 Joseph M. Cummins Treatment of immuno-resistant disease
WO1997007236A1 (en) 1995-08-18 1997-02-27 Landry Donald W Detection of organic compounds through regulation of antibody-catalyzed reactions
US6036949A (en) 1998-03-05 2000-03-14 Amarillo Biosciences, Inc. Treatment of fibromyalgia with low doses of interferon
US8188043B2 (en) 1999-07-28 2012-05-29 The Board Of Trustees Of The Leland Stanford Jr. University Nicotine in therapeutic angiogenesis and vasculogenesis
FR2859996B1 (fr) 2003-09-19 2006-02-03 Aventis Pharma Sa Solvat acetonique du dimethoxy docetaxel et son procede de preparation
WO2005048926A2 (en) 2003-11-13 2005-06-02 The General Hospital Corporation Methods for treating pain
CA2545968C (en) 2003-11-17 2010-03-09 Merck Eprova Ag Crystalline forms of (6r)-l-erythro-tetrahydrobiopterin dihydrochloride
JP5184783B2 (ja) 2003-11-17 2013-04-17 バイオマリン ファーマシューティカル インコーポレイテッド テトラヒドロビオプテリン、及びテトラヒドロビオプテリン類似体の製造方法
PT3138566T (pt) 2003-11-17 2022-02-02 Biomarin Pharm Inc Tratamento de fenilcetonúria com bh4
CN101132776A (zh) 2004-11-17 2008-02-27 生物马林药物股份有限公司 稳定的四氢生物喋呤片剂制剂
US20100130500A1 (en) 2004-12-08 2010-05-27 Biomarin Pharmaceutical Inc. Methods and compositions for the treatment of pulmonary hypertension of the newborn
WO2006118322A1 (en) 2005-04-28 2006-11-09 Shiratori Pharmaceutical Co., Ltd. Method for producing hydrazone derivatives
US20080075666A1 (en) 2006-08-25 2008-03-27 Dudley Samuel C Jr Methods and compositions for treating diastolic dysfunction
WO2010017570A2 (de) 2008-08-12 2010-02-18 Orpha Swiss Gmbh Pharmazeutische darreichungsform enthaltend tetrahydrobiopterin
US9884909B2 (en) 2010-12-01 2018-02-06 Alderbio Holdings Llc Anti-NGF compositions and use thereof
CA2828685C (en) * 2011-03-01 2018-05-29 Rubicon Research Private Limited Stable compositions of tetrahydrobiopterin
JP6084967B2 (ja) 2012-05-07 2017-02-22 白鳥製薬株式会社 セピアプテリン及びテトラヒドロラクトイルプテリンの製造法
EP3213062B1 (en) 2014-10-31 2020-02-12 Children's Medical Center Corporation Methods and assays relating to sepiapterin reductase inhibition
WO2018102315A1 (en) * 2016-11-29 2018-06-07 Censa Pharmaceuticals Inc. Polymoprhs of sepiapterin and salts thereof
CN110312721A (zh) 2016-11-29 2019-10-08 显莎制药公司 墨蝶呤的多晶型物
MX2020002271A (es) * 2017-09-01 2020-10-05 Ptc Therapeutics Mp Inc Composiciones farmaceuticas que comprenden sepiapterina y sus usos de las mismas.
JP7778477B2 (ja) * 2018-05-30 2025-12-02 ピーティーシー セラピューティクス エムピー,インコーポレイテッド セピアプテリンの薬学的に許容される塩
CA3102105A1 (en) 2018-05-30 2019-12-05 Ptc Therapeutics Mp, Inc. Compositions and methods for increasing tetrahydrobiopterin plasma exposure
JP7502197B2 (ja) 2018-05-30 2024-06-18 ピーティーシー セラピューティクス エムピー,インコーポレイテッド セピアプテリン血漿曝露を増加させるための方法
LT4009978T (lt) 2019-08-05 2024-11-25 Ptc Therapeutics Mp, Inc. Sepiapterino ir jo metabolitų panaudojimas spinduliuotės poveikio gydymui
IL291565B1 (en) 2019-09-25 2026-04-01 Ptc Therapeutics Inc Method for treating phenylalanine irregularity

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010523708A (ja) 2007-04-11 2010-07-15 バイオマリン ファーマシューティカル インコーポレイテッド テトラヒドロビオプテリンを投与する方法、関連する組成物および測定方法
WO2011132435A1 (ja) 2010-04-22 2011-10-27 学校法人日本大学 脳機能障害予防・改善用の薬剤及び飲食物
US20130108694A1 (en) 2011-11-02 2013-05-02 Biomarin Pharmaceutical Inc. Dry blend formulation of tetrahydrobiopterin

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
医薬品の臨床薬物動態試験について,医薬審発第七九六号,各都道府県衛生主管部(局)長あて厚生労働省医薬局審査管理課長通知,2001年06月01日

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CA3102105A1 (en) 2019-12-05
EP4748370A2 (en) 2026-05-27
PL3801534T3 (pl) 2026-07-06
FR26C1028I1 (fr) 2026-07-17
JP2021525746A (ja) 2021-09-27
EP4748370A3 (en) 2026-07-29
ES3068414T3 (en) 2026-05-29
EP3801534A1 (en) 2021-04-14
SMT202600220T1 (it) 2026-07-16
JP7855033B2 (ja) 2026-05-07
US20210161901A1 (en) 2021-06-03
SI3801534T1 (sl) 2026-06-30
LTPA2026521I1 (cg-RX-API-DMAC10.html) 2026-06-10
US20250195529A1 (en) 2025-06-19
JP2024178188A (ja) 2024-12-24
NO2026028I1 (no) 2026-05-29
MX2020012980A (es) 2021-04-29
CN112654356A (zh) 2021-04-13
FI3801534T3 (fi) 2026-04-14
LT3801534T (lt) 2026-05-25
NL301382I2 (nl) 2026-07-16
EP3801534B1 (en) 2026-02-18
MD3801534T2 (en) 2026-07-31
US12257252B2 (en) 2025-03-25
EP3801534A4 (en) 2022-03-16
WO2019232126A1 (en) 2019-12-05
RS68045B1 (sr) 2026-05-29
HRP20260360T1 (hr) 2026-06-05
DK3801534T3 (da) 2026-03-30
BR112020024329A2 (pt) 2021-02-23
PT3801534T (pt) 2026-04-28

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